Advanced Solid Tumor Clinical Trial
Official title:
A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients With Advanced Solid Tumors
A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors
Overall study design: This is an open-label, FIH, Phase I / II study of BT02 to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of BT02 in adult patients with advanced solid tumors. Safety monitoring committee (SMC) will be appointed for this study. The SMC includes the PIs, sub-Is, sponsor representatives, and/ or independent experts, to monitor the safety and scientific integrity of a human research intervention, and to make recommendations to the sponsor to continue, amend, or stop the study based on safety findings, efficacy, or for futility. The medical monitor will conduct a monthly systematic medical monitoring of the data during the study. ;
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